W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. […]
Structural Heart
Biotronik announces 100,000th implant of ICDs with AFib monitoring
Biotronik announced today that it hit 100,000 implanted single-lead implantable cardioverter defibrillators (ICDs) with DX Technology. DX Technology enables direct atrial sensing for AFib detection and monitoring. Since its introduction in 2009, clinicians in more than 80 countries around the world have used DX ICDs. The technology offers reliable, timely information about atrial arrhythmias and […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]
Olympus completes acquisition of GI stent maker Taewoong Medical
Olympus announced today that it closed its acquisition of Taewoong Medical, a Korea-based medical device manufacturer. Taewoong Medical develops gastrointestinal (GI) metallic stents, among other offerings. Olympus announced its intent to acquire the company for $370 million in February 2023. The deal includes $255.5 million upfront, with up to $114.5 million in potential milestone payments […]
Abbott reports double-digit growth across Medical Devices in Q4 as Diabetes, EP lead the way
Abbott today reported fourth-quarter earnings that included double-digit revenue growth across its entire Medical Devices unit. Shares of ABT fell more than 2% to nearly $111 apiece in morning trading. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly. The Abbott Park, Illinois–based medtech giant […]
FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
Cardiac Dimensions has a new chief medical officer
Cardiac Dimensions announced today that it appointed Dr. Satya Shreenivas as its new chief medical officer (CMO). Kirkland, Washington-based Cardiac Dimensions develops minimally invasive treatments for heart failure with functional mitral regurgitation (FMR). That includes the Carillon Mitral Contour System, for which the company has the ongoing EMPOWER trial. Its new CMO served as an […]
Gore enrolls first patients in expandable stent graft trial
W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft. The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition. Dr. […]
Medtronic brings back former VP as GM of Aortic unit
Medtronic announced that it named Dr. Simona Zannetti as the GM of its Aortic business unit. Zannetti previously spent 21 years at the medtech giant. She spent the last 16 months as SVP of clinical research at Penumbra, joining the interventional device maker in September 2022. In a LinkedIn post today, Nina Goodheart, SVP and […]
The biggest stories from the 2024 J.P. Morgan Healthcare Conference
Some of the biggest names in medtech came together this week at the J.P. Morgan Healthcare Conference. They shared updates on financial progress, operational changes and new products, among other things. Medtronic shared details on plans to restore earnings power, while Abbott highlighted the success of its FreeStyle Libre system. Shockwave Medical outlined its plans […]
Medtronic CEO: ‘Our top priority is restoring our earnings power — full stop.’
Medtronic Chair and CEO Geoff Martha focused on the push for profits at the world’s largest medical device manufacturer in his presentation at the J.P. Morgan Healthcare Conference today. “Our top priority is restoring our earnings power — full stop,” he said, citing Medtronic’s recent reorganizations and changes to incentives, product approvals and launches, and […]